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(Circulation. 1998;98:2800-2804.)
© 1998 American Heart Association, Inc.
Brief Rapid Communications |
Gene Therapy for Myocardial Angiogenesis
Initial Clinical Results With Direct Myocardial Injection of phVEGF165 as Sole Therapy for Myocardial Ischemia
From the Departments of Medicine, Biomedical Research, Surgery, and Anesthesiology, St. Elizabeth's Medical Center, Tufts University School of Medicine, Boston, Mass.
Correspondence to Jeffrey M. Isner, MD, St. Elizabeth's Medical Center, 736 Cambridge St., Boston, MA 02135.
Background—We initiated a phase 1 clinical study to determine the safety and bioactivity of direct myocardial gene transfer of vascular endothelial growth factor (VEGF) as sole therapy for patients with symptomatic myocardial ischemia.
Methods and Results—VEGF gene transfer (GTx) was performed in 5 patients (all male, ages 53 to 71) who had failed conventional therapy; these men had angina (determined by angiographically documented coronary artery disease). Naked plasmid DNA encoding VEGF (phVEGF165) was injected directly into the ischemic myocardium via a mini left anterior thoracotomy. Injections caused no changes in heart rate (pre-GTx=75±15/min versus post-GTx=80±16/min, P=NS), systolic BP (114±7 versus 118±7 mm Hg, P=NS), or diastolic BP (57±2 versus 59±2 mm Hg, P=NS). Ventricular arrhythmias were limited to single unifocal premature beats at the moment of injection. Serial ECGs showed no evidence of new myocardial infarction in any patient. Intraoperative blood loss was 0 to 50 cm3, and total chest tube drainage was 110 to 395 cm3. Postoperative cardiac output fell transiently but increased within 24 hours (preanesthesia=4.8±0.4 versus postanesthesia=4.1±0.3 versus 24 hours postoperative=6.3±0.8, P=0.02). Time to extubation after closure was 18.4±1.4 minutes; average postoperative hospital stay was 3.8 days. All patients had significant reduction in angina (nitroglycerin [NTG] use=53.9±10.0/wk pre-GTx versus 9.8±6.9/wk post-GTx, P<0.03). Postoperative left ventricular ejection fraction (LVEF) was either unchanged (n=3) or improved (n=2, mean increase in LVEF=5%). Objective evidence of reduced ischemia was documented using dobutamine single photon emission computed tomography (SPECT)-sestamibi imaging in all patients. Coronary angiography showed improved Rentrop score in 5 of 5 patients.
Conclusions—This initial experience with naked gene transfer as sole therapy for myocardial ischemia suggests that direct myocardial injection of naked plasmid DNA, via a minimally invasive chest wall incision, is safe and may lead to reduced symptoms and improved myocardial perfusion in selected patients with chronic myocardial ischemia.
Key Words: angiogenesis • ischemia • myocardium
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Y.-s. Yoon and D. W. Losordo All in the Family: VEGF-B Joins the Ranks of Proangiogenic Cytokines Circ. Res., July 25, 2003; 93(2): 87 - 90. [Full Text] [PDF]
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M. Hedman, J. Hartikainen, M. Syvanne, J. Stjernvall, A. Hedman, A. Kivela, E. Vanninen, H. Mussalo, E. Kauppila, S. Simula, et al. Safety and Feasibility of Catheter-Based Local Intracoronary Vascular Endothelial Growth Factor Gene Transfer in the Prevention of Postangioplasty and In-Stent Restenosis and in the Treatment of Chronic Myocardial Ischemia: Phase II Results of the Kuopio Angiogenesis Trial (KAT) Circulation, June 3, 2003; 107(21): 2677 - 2683. [Abstract] [Full Text] [PDF]
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S. Fleury, E. Simeoni, C. Zuppinger, N. Deglon, L. K. von Segesser, L. Kappenberger, and G. Vassalli Multiply Attenuated, Self-Inactivating Lentiviral Vectors Efficiently Deliver and Express Genes for Extended Periods of Time in Adult Rat Cardiomyocytes In Vivo Circulation, May 13, 2003; 107(18): 2375 - 2382. [Abstract] [Full Text] [PDF]
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I. Ahmet, Y. Sawa, T. Yamaguchi, and H. Matsuda Gene transfer of hepatocyte growth factor improves angiogenesis and function of chronic ischemic myocardium in canine heart Ann. Thorac. Surg., April 1, 2003; 75(4): 1283 - 1287. [Abstract] [Full Text] [PDF]
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N. Tomita, R. Morishita, Y. Taniyama, H. Koike, M. Aoki, H. Shimizu, K. Matsumoto, T. Nakamura, Y. Kaneda, and T. Ogihara Angiogenic Property of Hepatocyte Growth Factor Is Dependent on Upregulation of Essential Transcription Factor for Angiogenesis, ets-1 Circulation, March 18, 2003; 107(10): 1411 - 1417. [Abstract] [Full Text] [PDF]
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M. Nishida, T.-S. Li, K. Hirata, M. Yano, M. Matsuzaki, and K. Hamano Improvement of cardiac function by bone marrow cell implantation in a rat hypoperfusion heart model Ann. Thorac. Surg., March 1, 2003; 75(3): 768 - 773. [Abstract] [Full Text] [PDF]
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F. W. Sellke and M. Ruel Vascular growth factors and angiogenesis in cardiac surgery Ann. Thorac. Surg., February 1, 2003; 75(2): S685 - 690. [Abstract] [Full Text] [PDF]
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D. W. Losordo and A. Kawamoto Biological Revascularization and the Interventional Molecular Cardiologist: Bypass for the Next Generation Circulation, December 10, 2002; 106(24): 3002 - 3005. [Full Text] [PDF]
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 T. H. Kim, K. A. Skelding, E. G. Nabel, and R. D. Simari What can cardiovascular gene transfer learn from genomics: and vice versa? Physiol Genomics, December 3, 2002; 11(3): 179 - 182. [Abstract] [Full Text] [PDF]
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J.-S. Silvestre, N. Kamsu-Kom, M. Clergue, M. Duriez, and B. I. Levy Very-Low-Dose Combination of the Angiotensin-Converting Enzyme Inhibitor Perindopril and the Diuretic Indapamide Induces an Early and Sustained Increase in Neovascularization in Rat Ischemic Legs J. Pharmacol. Exp. Ther., December 1, 2002; 303(3): 1038 - 1043. [Abstract] [Full Text] [PDF]
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T. Funatsu, Y. Sawa, S. Ohtake, T. Takahashi, G. Matsumiya, N. Matsuura, T. Nakamura, and H. Matsuda Therapeutic angiogenesis in the ischemic canine heart induced by myocardial injection of naked complementary DNA plasmid encoding hepatocyte growth factor J. Thorac. Cardiovasc. Surg., December 1, 2002; 124(6): 1099 - 1105. [Abstract] [Full Text]
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A. Tandar, G.M. Saperia, and D.H. Spodick Direct myocardial revascularization and therapeutic angiogenesis Eur. Heart J., October 1, 2002; 23(19): 1492 - 1502. [Full Text] [PDF]
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M. C. Cid, J. Hernandez-Rodriguez, M.-J. Esteban, M. Cebrian, Y. S. Gho, C. Font, A. Urbano-Marquez, J. M. Grau, and H. K. Kleinman Tissue and Serum Angiogenic Activity Is Associated With Low Prevalence of Ischemic Complications in Patients With Giant-Cell Arteritis Circulation, September 24, 2002; 106(13): 1664 - 1671. [Abstract] [Full Text] [PDF]
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M. Ono, Y. Sawa, K. Matsumoto, T. Nakamura, Y. Kaneda, and H. Matsuda In Vivo Gene Transfection With Hepatocyte Growth Factor via the Pulmonary Artery Induces Angiogenesis in the Rat Lung Circulation, September 24, 2002; 106(12_suppl_1): I-264 - I-269. [Abstract] [Full Text] [PDF]
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T.-S. Li, K. Hamano, K. Suzuki, H. Ito, N. Zempo, and M. Matsuzaki Improved angiogenic potency by implantation of ex vivo hypoxia prestimulated bone marrow cells in rats Am J Physiol Heart Circ Physiol, August 1, 2002; 283(2): H468 - H473. [Abstract] [Full Text] [PDF]
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H. Su, J. Arakawa-Hoyt, and Y. W. Kan Adeno-associated viral vector-mediated hypoxia response element-regulated gene expression in mouse ischemic heart model PNAS, July 9, 2002; 99(14): 9480 - 9485. [Abstract] [Full Text] [PDF]
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Y. Taniyama, R. Morishita, M. Aoki, K. Hiraoka, K. Yamasaki, N. Hashiya, K. Matsumoto, T. Nakamura, Y. Kaneda, and T. Ogihara Angiogenesis and Antifibrotic Action by Hepatocyte Growth Factor in Cardiomyopathy Hypertension, July 1, 2002; 40(1): 47 - 53. [Abstract] [Full Text] [PDF]
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H. Franz Alber, J. Dulak, M. Frick, W. Dichtl, S. Paul Schwarzacher, O. Pachinger, and F. Weidinger Atorvastatin decreases vascular endothelial growth factor in patients with coronary artery disease J. Am. Coll. Cardiol., June 19, 2002; 39(12): 1951 - 1955. [Abstract] [Full Text] [PDF]
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E. Leotta, G. Patejunas, G. Murphy, J. Szokol, L. McGregor, J. Carbray, A. Hamawy, D. Winchester, N. Hackett, R. Crystal, et al. Gene therapy with adenovirus-mediated myocardial transfer of vascular endothelial growth factor 121 improves cardiac performance in a pacing model of congestive heart failure J. Thorac. Cardiovasc. Surg., June 1, 2002; 123(6): 1101 - 1113. [Abstract] [Full Text] [PDF]
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S.-i. Yoshimura, R. Morishita, K. Hayashi, J. Kokuzawa, M. Aoki, K. Matsumoto, T. Nakamura, T. Ogihara, N. Sakai, and Y. Kaneda Gene Transfer of Hepatocyte Growth Factor to Subarachnoid Space in Cerebral Hypoperfusion Model Hypertension, May 1, 2002; 39(5): 1028 - 1034. [Abstract] [Full Text] [PDF]
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K. Hamano, T.-S. Li, T. Kobayashi, K. Hirata, M. Yano, M. Kohno, and M. Matsuzaki Therapeutic angiogenesis induced by local autologous bone marrow cell implantation Ann. Thorac. Surg., April 1, 2002; 73(4): 1210 - 1215. [Abstract] [Full Text] [PDF]
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M. C. Kim, A. Kini, and S. K. Sharma Refractory angina pectoris: Mechanism and therapeutic options J. Am. Coll. Cardiol., March 20, 2002; 39(6): 923 - 934. [Abstract] [Full Text] [PDF]
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C. L. Grines, M. W. Watkins, G. Helmer, W. Penny, J. Brinker, J. D. Marmur, A. West, J. J. Rade, P. Marrott, H. K. Hammond, et al. Angiogenic Gene Therapy (AGENT) Trial in Patients With Stable Angina Pectoris Circulation, March 19, 2002; 105(11): 1291 - 1297. [Abstract] [Full Text] [PDF]
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M.-H. Liu, H. Jin, H. S. Floten, Z. Ren, A. P.C. Yim, and G.-W. He Vascular endothelial growth factor-mediated, endothelium-dependent relaxation in human internal mammary artery Ann. Thorac. Surg., March 1, 2002; 73(3): 819 - 824. [Abstract] [Full Text] [PDF]
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A. Scherpereel, J. J. Rome, R. Wiewrodt, S. C. Watkins, D. W. Harshaw, S. Alder, M. Christofidou-Solomidou, E. Haut, J.-C. Murciano, M. Nakada, et al. Platelet-Endothelial Cell Adhesion Molecule-1-Directed Immunotargeting to Cardiopulmonary Vasculature J. Pharmacol. Exp. Ther., March 1, 2002; 300(3): 777 - 786. [Abstract] [Full Text] [PDF]
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J M Cotton, M R Thomas, B J Dunmore, J Salisbury, A M Shah, and N P J Brindle Angiogenesis in chronically ischaemic human heart following percutaneous myocardial revascularisation Heart, March 1, 2002; 87(3): 281 - 283. [Full Text] [PDF]
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M. Shimpo, U. Ikeda, Y. Maeda, M. Takahashi, H. Miyashita, H. Mizukami, M. Urabe, A. Kume, T. Takizawa, M. Shibuya, et al. AAV-mediated VEGF gene transfer into skeletal muscle stimulates angiogenesis and improves blood flow in a rat hindlimb ischemia model Cardiovasc Res, March 1, 2002; 53(4): 993 - 1001. [Abstract] [Full Text] [PDF]
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H El-Gendi, A G Violaris, R Foale, H S Sharma, and D J Sheridan Endogenous, local, vascular endothelial growth factor production in patients with chronic total coronary artery occlusions: further evidence for its role in angiogenesis Heart, February 1, 2002; 87(2): 158 - 159. [Full Text] [PDF]
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J. Rockstroh and B. G. Brown Coronary Collateral Size, Flow Capacity, and Growth: Estimates From the Angiogram in Patients With Obstructive Coronary Disease Circulation, January 15, 2002; 105(2): 168 - 173. [Abstract] [Full Text] [PDF]
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 J.A. NAGY, E. VASILE, D. FENG, C. SUNDBERG, L.F. BROWN, E.J. MANSEAU, A.M. DVORAK, and H.F. DVORAK VEGF-A Induces Angiogenesis, Arteriogenesis, Lymphangiogenesis, and Vascular Malformations Cold Spring Harb Symp Quant Biol, January 1, 2002; 67(0): 227 - 238. [Abstract] [PDF]
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